NCT03168438

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma

Open-Label Pilot Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells Alone or in Combination With Pembrolizumab in HLA-A2+ Subjects With NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate safety, tolerability, and efficacy of letetresgene autoleucel (GSK3377794) with or without pembrolizumab in participants with relapsed and refractory multiple myeloma.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	Letetresgene autoleucel	Letetresgene autoleucel (GSK3377794) as an IV infusion
DRUG	Letetresgene autoleucel with pembrolizumab	Letetresgene autoleucel (GSK3377794) as an IV infusion, followed by pembrolizumab every 3 weeks
DRUG	Fludarabine	Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
DRUG	Cyclophosphamide	Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
DRUG	Pembrolizumab	Pembrolizumab is available as an IV infusion

Timeline

• Start date: 2017-08-18
• Primary completion: 2020-07-13
• Completion: 2020-11-05
• First posted: 2017-05-30
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study